MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6).Date of this report: 07-may-2020.

Event Description

The customer originally reported a flow test failure.There was no patient involvement.Additional information of a display issue was found later.The field service engineer fse confirmed the failures.The fse replaced the gas delivery system to fix the flow test issue and the display was replaced to fix a lighting issue.The unit passed performance verification and was returned to service.

Manufacturer Narrative

G4: 14sep2020 b4: 05nov2020 the gas delivery system (gds) was returned to manufacturer to failure investigation (fi) for analysis.Customer complaint verified.Root cause was failure of airflow sensor, caused by u1 drifting out of calibration.The determination could be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4: 24aug2020.B4: 28aug2020.The liquid crystal display (lcd) user interface was returned to manufacturer failure investigation (fi) for analysis.The burn out cold cathode fluorescent lamp (ccfl) backlight causes the dim display.The determination could be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4: 10nov2020, b4: 10nov2020.The customer reported problem of failing flow accuracy test is part of the performance verification test (pvt).It is a required test before patient use.This is to ensure the ventilator operates within the manufacturing specifications.Any failures that occurred during the pvt will always be found and prior to placing the ventilator into patient use.Based on the information, the flow test issue does not meet the criteria for a reportable incident.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 10037018
• MDR Text Key: 190522141
• Report Number: 2031642-2020-01681
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1